Latex Content in Nellcor™, Nellcor™ Puritan Bennett, Mallinckrodt® Anesthesiology Products and Shiley® Tracheostomy Products Thank you for your interest in Nellcor™ products. The following information is to assist our customers and distributors in quickly and accurately identifying which Nellcor™ products contain latex. Effective September 28, 1998, the United States Food and Drug Administration required that all medical device manufacturers label products that contained dry natural rubber or natural rubber latex in the product Directions for Use. Unless otherwise described in this website or the device packaging and/or Directions for Use, to the best of our knowledge, Nellcor™, Nellcor™ Puritan Bennett, Mallinckrodt anesthesiology products and Shiley tracheostomy products do not contain dry natural rubber or natural rubber latex. If you have questions about the latex status of a particular product, please consult the product Directions for Use. If you can not locate the product Directions for Use, please contact your local sales representative.
Nellcor™ Anesthesia & Respiratory Products The anesthesia and respiratory products in the table immediately under this line contain latex.
The following model of Infusors contain latex (hand pump and hand pump tubing &en; HP and HPDC versions only)
AD500HP below serial number 13445 AD500HPDC below serial number 13100 AD1000HP below serial number 1-6546 AD1000HPDC below serial number 1-6446
**This product has latex components which do not come in direct contact with the patient's skin. There is no known risk associated with this product due to the presence of latex.
Blood Pressure Cuffs The supplier of the reusable blood pressure cuffs has informed us that the internal cuff bladders contain latex. The products are listed below:
These cuff bladders are enclosed in a Dacron bag that includes a urethane lining barrier, however the hose that extends from the cuff may also contain latex. For blood pressure cuffs shipped after February 1, 1997, the blood pressure cuff hose has been treated to provide an external coating of neoprene over the exposed area, to minimize the likelihood of latex containing parts making skin contact. The shipping date of the cuff can be determined by examining the date code on the Dacron flap of the blood pressure cuff. The Dacron flap is normally tucked inside the cuff at the hose insertion point. The Nellcor™ Puritan Bennett SHBP-10 Hose (which interfaces between the monitor and blood pressure cuff) does not contain latex. At present, we have not validated any other vendors' reusable cuffs. Latex free neonatal cuffs are available for use with the N-3100.
Combitube® and Combitube S.A. The Combitube® airway has always contained and presently does contain natural rubber latex in the pharyngeal cuff.
Mallinckrodt® Endotracheal Tubes: All endotracheal tubes are latex free.
Oximetry Sensors In the past, the adhesive coating of the bandage on the Oxisensor® II oxygen sensor models I-20, I-20R, N-25 and N-25R, OxiCliq-N®, OxiCliq-I® oxygen sensors and the ADH-A/N disposable wraps, may have contained a minute amount of natural latex. Please note that this material is the same type used in commercial adhesive bandages. Please see below for current information on these products and other sensors.
In the past, latex-free oxygen sensors Oxisensor II N-25LF and I-20LF were made to meet customer needs. The letters LF indicated these products to be LATEX FREE. As of April 2001, the Oxisensor II oxygen transducers I-20 and N-25 have been standardized and are now labeled as LATEX-FREE. The letters LF have been removed from the product number to minimize redundancy. The initial lot number for latex free I-20s is C29017 and the initial lot number for latex free N-25s is C29018.
As of June 2002, the OxiCliq-N and OxiCliq-I oxygen sensors are latex free.
As of January 2002, the ADH-A/N is latex free.
Private label NOVAPLUS pulse oximetry sensors VN-25 and VI-20 are identical in quality and material to the Nellcor™ Oxisensor II oxygen sensors N-25 and I-20. They are also latex free.
On earlier RS-10 reflectance oxygen sensors, the patient contact surface and the double-sided adhesive tabs contained no natural latex. However, natural latex was a component in the adhesive used to bond the layers within the sensor. These layers are above the patient contact surface. The adhesive materials used in the sensors referenced above have been tested using the Latex ELISA Antigenic Protein (LEAP) Assay of Biomedical Extract testing at a nationally recognized independent testing laboratory. No latex antigen was detected in this test. This test has a lower detection limit of 0.03 micrograms/milliliter.
Shiley® Tracheostomy Products The Shiley tracheostomy tube and accessory products are composed of medical grade plastics that do not contain latex material. All packaging of Shiley tracheostomy products are free of latex.
Ventilator and Respiratory Accessory Products The following Puritan-Bennett ventilator systems do not contain latex: 740™, 760™, 840™ (including the 806 compressor).
The 7200® series ventilator does not contain latex components that would come in contact with patients or users.
The ventilator and respiratory accessory parts listed in the following table have been confirmed to contain latex:
Miscellaneous Products - Content Not Yet Determined The latex content status of the parts listed in the following table has not yet been confirmed. Until the latex content status of these parts is resolved, we suggest that they be assumed to contain latex.
Packaging of Nellcor™ Critical Care Products All packaging of Nellcor™ Critical Care Products are free of latex. The table immediately following this line is a quick reference guide to latex free products.
Customer Inquiries About Latex in Products For questions about Nellcor™, Nellcor™ Puritan Bennett, Mallinckrodt, Aequitron™, EdenTec™ or Infrasonics products or versions not listed, please contact:
For Mallinckrodt, Liebel-Flarsheim, Shiley products, including those from Imaging, Pharmaceuticals, Nuclear Medicine, Critical Care and Mallinckrodt Baker:
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